Active Ingredient
Pelargonium sidoides 1X
Cold Relief Lemon Powder
FDA Label NDC 53499-6146
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Cold Relief Lemon (NDC 53499-6146). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, dosage & administration, indications & usage, purpose, warnings, ask the doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Citric Acid
Maltodextrin
Natural Flavor
Silica
Turmeric Color
Xylitol
Dosage & Administration
Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.
May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.
For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults and children 13 years of age and older: Take 1 packet three times daily.
Children 6-12 years of age: Take 1 packet two times daily.
Children under 6 years of age: Consult a doctor.
Indications & Usage
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
Purpose
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
Warnings
Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a physician promptly.
Ask The Doctor
Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergey to plants of the Geraniaceae family.
Stop Use
Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.
These could be signs of a serious condition.
Pregnant Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Overdose
In case of overdose, seek medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
